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NCT Number: NCT06103968

Influence of Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster

Since its invention in 1981 by Dr. Archie Brain, the classical laryngeal mask airway (LMA ) has undergone many modifications. Today various LMAs are available that can also help in Ryle's tube insertion, intubation via LMA, deep extubation, adjunct in difficult airway and for spontaneous ventilation in short procedures.

One of the newer modifications is the Blockbuster LMA. It was invented by Prof. Ming Tian, the president of Chinese Difficult Airway Society and is being increasingly used for cases of difficult intubation. It has some unique features like its 95 degrees angulated airway that makes it easier to insert. It also has a gastric port and provides better sealing pressures at lower volumes.

However the one of the major concern with supraglottic airway is that despite correct placement it may dislodge, or its position may change intraoperatively especially in surgeries where patient position needs to be changed or patient is moved/transferred or head and neck surgeries.

In this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.

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Key information

Conditions

Anesthesia

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jawaharlal Nehru Medical College

Aligarh, Uttar Pradesh, 450331, India

About this study

Following approval by the Board of studies, Department of anaesthesiology and ethical committee of this institution the study will be conducted in J N Medical College and hospital on 60 patients undergoing operative procedures under general anaesthesia. Patients will be included in the study after well informed written consent, including the information that they would be part of this ongoing institutional research.

STUDY DESIGN Prospective randomised controlled study

STUDY POPULATION The study will be conducted on 60 patients admitted to JNMCH, AMU Aligarh planned for operative procedure under general anaesthesia.

In this study investigator wishes to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Grade I & II patients
  • Age between 20-70 years
  • Weight between 40-70 kg
  • Patients of both sexes
  • All classes of MP Grades

Exclusion criteria

  • Any pathology of the oral cavity that may obstruct the insertion of device
  • Mouth opening less than 2.5cm.
  • Potentially full stomach patients (trauma, morbid obesity, history of gastric regurgitation and heart burn, full term pregnancy)
  • risk of oesophageal reflux (hiatus hernia)
  • Bleeding disorder
  • Unable to provide informed consent

Treatment and study plan

LMA BLOCKBUSTER

Device

In this study we wish to evaluate weather gastric tube inserted through LMA helps in maintaining the LMA blockbuster placement by comparing fibreoptic bronchoscope (FOB) scores recorded immediately after LMA placement and at the end of the surgical procedure.

Other names: GASTRIC TUBE

Primary outcomes

  1. POGO SCORE

    Time frame: IMMEDIATELY AFTER LMA PLACEMENT AND AT THE END OF SURGERY JUST BEFORE REMOVAL OF LMA

    Grading the placement of LMA blockbuster through Fibreoptic Bronchoscope score of at the start and end of the surgery.

Secondary outcomes

  1. GASTRIC TUBE INSERTION SUCCESS RATE

    Time frame: within 2 minutes of LMA Blockbuster placement

    Ease and success rate of gastric tube insertion; number of attempts taken if successfull

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study title

Determining the Influence Gastric Tube Presence in Upholding the Correct Placement of LMA Blockbuster During Surgery.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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